Life Sciences Horizons Brochure 2025 - Flipbook - Page 10
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2025 Horizons Life Sciences and Health Care
EU efforts to address medicine shortages expand in 2025
In 2025, the EU continues to strengthen its regulatory
framework to address the persistent challenge of
medicine shortages. The European Medicines Agency
(EMA) and the European Commission have introduced
several measures to ensure the availability of essential
medicines in all Member States. This article provides
an overview of these upcoming changes, which are
crucial for pharmaceutical companies operating in
the EU.
Launch of the European Shortages Monitoring
Platform (ESMP)
One of the most anticipated developments is the full
launch of the European Shortages Monitoring Platform
(ESMP) on 02 February 2025. This platform will serve
as a centralized hub for data collection on medicine
shortages, enhancing the EU's ability to prevent,
detect, and manage shortages effectively. Marketing
authorization holders will be required to report any
shortages through the ESMP, ensuring a timely and
accurate flow of information. This initiative aims to
improve the coordination and response to shortages.
Upcoming pharma law package
One of the main objectives of the European Commission’s
proposal to reform EU pharmaceutical legislation
with a new directive and regulation (the “Pharma Law
Package”), is to prevent shortages. Under the proposed
legislation, marketing authorization applicants will
be obliged to establish a shortage prevention plan, to
anticipate any potential future shortages. The Pharma
Law Package and the measures included in this package
are still in the law-making process and are not expected
to enter into force before the end of 2026.
Conclusion
The measures introduced by the EMA and the European
Commission reflect a proactive approach to safeguarding
the supply of medicines within the EU. The launch of
the ESMP, the updated Union List of Critical Medicines,
and the Pharma Law Package are aimed towards a
more resilient and responsive health care system.
Pharmaceutical companies should stay informed on
these regulatory changes to ensure compliance, and to
continue providing essential medicines to patients across
the EU.
Updated union list of critical medicines
In December 2024, the EMA updated the Union List of
Critical Medicines. The list, which includes over 300
medicines, identifies medicines that are essential for
public health, and aims to support and accelerate the
analysis of the supply chain of critical medicines to
identify potential vulnerabilities. By focusing on these
critical medicines, the EMA aims to mitigate the impact
of potential shortages on patient care and public health.
Hein van den Bos
Partner
Amsterdam
Julia Mischie
Associate
Amsterdam
Milan Tuijp
Junior Associate
Amsterdam
